June 29, 2016
Executive Director, Colorado Department ofHealthcare Policy and Finance
1570 Grant St.
Denver, Colorado 80203
Dear Director Sue Birch,
As the largest provider of health care for low-income individuals in Denver, we are concerned that the current Medicaid restrictions on treatment for Hepatitis C (HCV) infection are leading to worsening morbidity, mortality, and health disparities. We strongly encourage HCPF to make curative therapy more broadly available, in accordance with guidance from the Centers for Medicare and Medicaid Services.
HCV causes a chronic infection in 70-80% of infected persons, leading to severe, irreversible liver damage (advanced fibrosis and cirrhosis) in 20-30% of individuals with persistent infection. Furthermore, HCV infection at all stages of liver fibrosis is associated with adverse health effects. The burden of HCV-related disease is alarming; CDC estimates that HCV kills more people than the 60 other reportable infections combined. Fortunately, new medications are now available that reliably cure HCV and are very well tolerated. Furthermore, treatment can prevent transmission to others. Treatment as prevention is working for HIV disease: widespread use of antiretroviral therapy has decreased the rate of new HIV infections in Denver by more than 60% over the past decade. Despite these benefits to the individual and the community, a recent analysis from the state’s all-payer claims database estimated that only 10% of individuals living with chronic HCV in Colorado have been treated.
Current Colorado Medicaid guidelines require evidence of stage 3 or 4 liver fibrosis. This restriction is problematic for several reasons. First, staging is imprecise. What is assigned F2 on a biopsy may actually be F3 or F4 but the pathology report may inaccurate due to sampling error. Second, the rate of progression to cirrhosis is not always linear. Once a person has F2 fibrosis, progression to cirrhosis may occur quickly. Thus, a person denied treatment for an F2 score one year may present for follow up a year later and be diagnosed with cirrhosis, which is irreversible and associated with an increased risk of cancer and death, even after HCV infection is cured. Third, access to the accepted staging methods is limited. Liver biopsy is associated with a low but significant risk of serious complications including hemorrhage and therefore no longer the preferred staging modality. Fourth, HCV infection is more difficult to cure when individuals develop cirrhosis. Finally, individuals with all levels of fibrosis have been shown to have significant rates of extrahepatic disease (kidney disease, hypertension, lymphoma, diabetes, intractable fatigue, arthritis, vasculitis, thyroid disease, depression, memory loss).
The second major area of concern regarding current Colorado Medicaid HCV treatment restrictions is the requirement that individuals be free of illicit substances, alcohol and marijuana for six months prior to approval of treatment. This restriction is not evidence-based and restricts access to treatment for many individuals with advanced HCV liver disease. Several studies have demonstrated successful treatment ofHCV among drug users. Most ofthe drugs prohibited by the restrictions (including marijuana) have no effect on liver health. Furthermore, we are not aware of other diseases for which treatment is restricted for Medicaid recipients based on lifestyle choices.
Access to specialty care is often very limited for patients with Medicaid in Colorado. Reports from around the country demonstrate high levels of success with primary care-based treatment of HCV. Thus, eliminating the specialty provider restriction could have tremendous benefit to Colorado Medicaid recipients.
HCV disproportionately affects lower income populations. Current Colorado Medicaid treatment restrictions may worsen socio-economic health disparities. Our experience providing HCV treatment at Denver Health reveals an alarming disparity in access to care. Patients covered by Medicare and commercial insurance are universally approved for HCV treatment with new treatment regimens. However, the vast majority of our patients enrolled in Colorado Medicaid have been denied access to treatment for the reasons listed above. Even individuals with advanced disease (compensated cirrhosis) who are at the highest risk of severe complications of HCV infection are denied treatment by Medicaid if substance use disorders exist. Finally, limiting approved HCV treatment prescribers to specialists creates unnecessary barriers for Medicaid patients. For these reasons, morbidity and mortality from HCV-related illness will continue to increase among our state’s lowest income residents.
Real World Experience
Current HCV treatment regimens are very safe and highly-effective. More than 6,000 patients have participated in phase 3 clinical trials of the recommended regimens. From hcvguidelines.org: “The safety profiles of all the recommended regimens above are excellent. Across numerous phase III programs, less than 1% of patients without cirrhosis discontinued treatment early and adverse events were mild. Discontinuation rates were higher for patients with cirrhosis (approximately 2% for some trials) but still very low.”
The experience of treating HCV-HIV co-infected patients in the Denver Health Infectious Diseases Clinic and University of Colorado Infectious Diseases Group Practice Clinic illustrates the real-world efficacy of therapy in a high-risk group. In 2015, our clinics treated a total of 93 co-infected patients. The cure rate for individuals who completed treatment and were assessed for sustained virologic response was 96%. Only two patients were lost to follow-up while on treatment, one patient’s treatment was stopped for an unrelated medical event, and three patients with severe liver disease (two were on the liver transplant list) failed treatment. No patient stopped treatment for a medication related side effect or adverse event. Twenty patients had evidence of active substance abuse and nearly all were successfully treated through the AIDS Drug Assistance Program (which does not restrict treatment of individuals with addictions or substance use disorders).
While treatment is relatively expensive, prices are decreasing as new medications are approved (see Figure). Meanwhile, the costs of withholding HCV treatment are growing. In the past decade, hepatocellular carcinoma cases have doubled in Denver and hospitalizations for HCV-related conditions are steadily increasing. Multiple studies have shown that treatment with these new regimens cuts hospitalizations in half and leads to significantly lower follow-up healthcare costs compared to untreated individuals.
Importantly, the evidence from other states demonstrates that expanding access will not result in dramatically increased treatment costs. Only a minority of HCV-infected persons will seek care in a given year and they must complete the stages of diagnosis, linkage to care, and initial medical evaluation prior to initiating treatment. Mass Health, Massachusetts’ Medicaid program, reported that in the first 18 months after treatment restrictions were eliminated, only 14% ofHCV-infected individuals in their administrative database were treated. Similar findings were noted in New York.
A phased approach to expanding access to treatment can allow broader access to treatment while controlling treatment costs. In California, the Medicaid program has eliminated urine drug and alcohol screens and extended treatment access to individuals with F2 or greater fibrosis, leading to better health care access for California residents, while still maintaining a prioritization process that cushions the Medicaid program from the full impact ofHCV costs for the next couple of year as medication prices decrease.
Without a change, HCV treatment policies for Colorado Medicaid may be made in a courtroom, rather than in the exam room. Medicaid treatment restrictions in Washington state resulted in a federal court ruling that all restrictions be eliminated, a more costly outcome than the three changes to treatment restrictions that we recommend above. Similar lawsuits are underway regarding the Indiana Medicaid program and two state prison systems. Colorado should follow the lead of Medicaid programs in Florida, Connecticut, New York and Pennsylvania in increasing access to treatment rather than engage in expensive legal battles.
While we believe that all individuals living with chronic HCV need treatment, three revisions to the current CO Medicaid treatment criteria would substantially improve access, while controlling the costs of treatment. First, we recommend removing drug and alcohol restrictions from the prior approval process so that all individuals with evidence of advanced disease can be treated. Second, we recommend extending treatment access to individuals with any evidence of F2 fibrosis. Third, we recommend that primary care providers be able to prescribe HCV treatment.
William J. Burman, M.D.
Interim CEO, Denver Health and Hospital Authority